Apparatus and process for producing porous devices

ABSTRACT

In general, in various embodiments, the present disclosure is directed systems and methods for producing a porous surface from a solid piece of polymer. In particular, the present disclosure is directed to systems that include a track assembly, mold assembly, press assembly, and methods for using the same for producing a porous surface from a solid piece of polymer. In some embodiments, the present systems and methods are directed to processing a polymer at a temperature below a melting point of the polymer to produce a solid piece of polymer with an integrated a porous surface.

CROSS REFERENCE TO RELATED APPLICATIONS

This Application is a continuation of U.S. patent application Ser. No.14/985,226, filed Dec. 30, 2015, entitled “APPARATUS AND PROCESS FORPRODUCING POROUS DEVICES”, by Wei-Hsiang Chang, et al, pending, which isincorporated herein by reference in its entirety and is acontinuation-in-part application and claims the benefit of and priorityunder 35 U.S.C. §120 to:

U.S. patent application Ser. No. 14/747,660, filed Jun. 23, 2015,entitled “Medical Device with Porous Surface and Method for ProducingSame”, by Wei-Hsiang Chang, et al, now U.S. Pat. No. 9,353,235, which isa continuation of U.S. patent application Ser. No. 14/587,856, filedDec. 31, 2014, entitled “Method for Producing Porous Material”, byWei-Hsiang Chang, et al., now U.S. Pat. No. 9,085,665, each of which arehereby incorporated by reference herein as if set forth herein in theirentireties; and

U.S. patent application Ser. No. 14/752,762, filed Jun. 26, 2015,entitled “Porous Devices and Processes for Producing Same”, byWei-Hsiang Chang, et al, pending, which is a continuation-in-partapplication of U.S. patent application Ser. No. 14/587,856, filed Dec.31, 2014, entitled “Method for Producing Porous Material”, by Wei-HsiangChang, et al., now U.S. Pat. No. 9,085,665 and claims the benefit of andpriority to U.S. Provisional Patent Application No. 62/017,834, filedJun. 26, 2014, entitled “Polymer Layer with Increased Wettability”, eachof which are hereby incorporated by reference herein as if set forthherein in their entireties.

TECHNICAL FIELD

The present disclosure relates generally to apparatuses and processesfor creating porous devices.

BACKGROUND

Polymers have been shown to have many advantageous mechanical andchemical properties such as imperviousness to water, low toxicity,chemical and heat resistance, and shape-memory properties. Additionally,polymers are often relatively low cost, easy to manufacture, andversatile in application. These characteristics have led to the use ofpolymers in many applications such as, for example, medical devices,electronics, optics, computing, and a wide-array of consumer products.

Adding pores to one or more surfaces of a polymer structure may providefurther advantages, such as, for example, increasing friction at the oneor more porous surfaces and providing better device integration insurgical applications by promoting adjacent tissue in-growth. However,as will be understood by one of ordinary skill in the art, introducingporosity into polymers may, in some instances, weaken desired mechanicalproperties, such as shear strength at the porous surface. Thus, althoughintroducing pores into such polymers may have certain advantages, it hasbeen limited in application due to a loss in mechanical properties.

BRIEF SUMMARY OF THE DISCLOSURE

One aspect of the present disclosure generally relates to producing aporous surface from a solid piece of polymer. In particular, producing aporous surface from a solid piece of polymer at a processing temperaturebelow a melting point of the polymer to produce a solid piece of polymerwith a porous surface integrated into the solid piece of polymer.

According to particular aspects, a method including: 1) loading a solidbody of material and porogen into a mold that is configured to travelalong a predetermined path; 2) applying pressure via a press to thesolid body of material for displacing the porogen through the surface bya defined distance, creating, thereby, a matrix layer including thematerial and the porogen in the solid body of material, the matrix layerbeing integrally connected with the solid body of material; 3)maintaining, via a heating element located along the predetermined path,throughout the heating and displacing steps, a temperature of thesurface of the solid body that is below the melting temperature by atleast the melting temperature differential; and 4) unloading the solidbody of material from the mold and removing the porogen to create anintegrally connected porous layer in the solid body of material.

According to at least one aspect, a method for processing material, themethod comprising: 1) providing a piece of polymer for processing; 2)pressing a surface of the piece of polymer against a layer of porogenvia a static weight; 3) while the piece of polymer is pressed againstthe layer of porogen, subjecting the piece of polymer to at least oneheat zone along a track assembly, wherein the at least one heat zoneheats the material to a particular temperature for a particular time; 4)further pressing the piece of polymer against the layer of porogen via apress assembly such that at least a portion of the layer of porogen isdisplaced through a surface of the piece of polymer to create a matrixlayer of porogen and the polymer; and 5) removing the porogen from thematrix layer of the polymer thereby creating a porous layer of thepolymer.

According to some aspects, a method comprising: 1) loading a solid bodyof material and porogen into a mold; 2) heating, via a heating elementlocated along a processing path, a surface of the solid body of materialto a processing temperature that is below a melting temperature of thematerial by a melting temperature differential; 3) increasing heat fromthe processing temperature while applying a constant pressure to thesolid body of material for displacing the porogen through the surface bya defined distance, creating, thereby, a matrix layer including thematerial and the porogen in the solid body of material, the matrix layerbeing integrally connected with the solid body of material; 4)maintaining throughout the heating and displacing steps, the constantpressure on the solid body of material; 5) cooling the solid body ofmaterial once the porogen is displaced through the surface by a defineddistance; and 6) unloading the solid body of material from the mold andremoving the porogen to create an integrally connected porous layer inthe solid body of material.

According to one or more aspects, a method for processing material, themethod comprising: 1) providing a thermoplastic for processing; 2)providing a porogen for creating a porous layer in the thermoplastic; 3)providing a track assembly comprising at least one heating element forheating the thermoplastic; 4) providing a static weight for applying aconstant pressure to the thermoplastic; 5) providing a press assemblyfor applying an increased pressure to the thermoplastic; 6) loading theporogen and thermoplastic onto the track assembly, wherein a surface ofthe thermoplastic is in contact with the porogen; 7) applying theconstant pressure to the thermoplastic via the static weight andapplying heat to the thermoplastic via the heating element; 8) applyingthe increased pressure to the thermoplastic via the press assembly fordisplacing the porogen through the surface of the thermoplastic; 9)removing the increased pressure and heat from the thermoplastic to allowthe thermoplastic to cool; 10) removing the constant pressure from thethermoplastic; and 11) removing the porogen from the thermoplastic,thereby creating a porous layer of the thermoplastic integrally formedwithin a surface of the thermoplastic.

In various embodiments, an apparatus for processing a material, theapparatus comprising: 1) a work bench assembly; 2) a mold assembly, themold assembly comprising: a)an outer mold body defining an opening forreceiving a mold insert; b) the mold insert comprising a void forreceiving a layer of porogen and a piece of thermoplastic material; andc) a static weight for applying pressure to the a piece of thermoplasticmaterial; 3) a track assembly operatively connected to the work benchassembly, the track assembly comprising: a) a frame; b) at least onetrack guide operatively connected to the frame, the at least one trackguide defining a path of travel for the mold assembly; c) two or moreelectrical resistance heating elements located under the at least onetrack guide, wherein the two or more electrical resistance heatingelements heat the mold assembly to at least one predetermined processingtemperature; and d) one or more indexers for moving the mold assemblyalong the path of travel; and 4) a press operatively connected to thework bench assembly, the press assembly for applying pressure the pieceof the thermoplastic material, wherein the pressure applied by the pressis in addition to the pressure applied by the static weight.

In particular embodiments, an apparatus for processing a material, theapparatus comprising: 1) a mold, the mold configured to receive aporogen and a piece of material for processing; 2) a track for guidingthe mold along a predefined processing path; 3) a heating element at afirst particular portion of the processing path for heating thematerial; and 4) a press for applying force to the material at a secondparticular portion of the processing path.

In at least one embodiment, an apparatus for producing a porousmaterial, the apparatus comprising four (4) sections, wherein: 1) afirst section of the apparatus comprises an area for loading a solidpiece of material and porogen into a mold; 2) a second section of theapparatus comprises a first heating element for heating the solid pieceof material to a particular processing temperature; 3) a third sectionof the apparatus comprises a second heating element for holding theprocessing temperature; and 4) a further section of the apparatuscomprises a press for applying pressure to the piece of material forcausing the porogen to displace within a surface of the piece ofmaterial.

In some embodiments, an apparatus for producing a porous material, theapparatus comprising: 1) a means for receiving a particular piece ofmaterial and at least one layer of porogen; 2) a means for pressing theparticular piece of material against the at least one layer of porogen;and 3) a means for guiding the particular piece of material along apredefined path, wherein the predefined path includes: a) a means forheating the particular piece of material to a particular processingtemperature; and b) a means for applying pressure to the particularpiece of material to displace at least some of the at least one layer ofporogen into the particular piece of material.

These and other aspects, features, and benefits of the claimed systemsand methods will become apparent from the following detailed writtendescription of the preferred embodiments and aspects taken inconjunction with the following drawings, although variations andmodifications thereto may be effected without departing from the spiritand scope of the novel concepts of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exemplary apparatus for producing porous devicesaccording to one aspect of the present disclosure.

FIG. 2 shows the exemplary apparatus of FIG. 1, with a mold in a firstexemplary position according to one embodiment of the presentdisclosure.

FIG. 3 shows the exemplary apparatus of FIG. 1, with a mold in a secondexemplary position according to one embodiment of the presentdisclosure.

FIG. 4 shows the exemplary apparatus of FIG. 1, with a mold in a thirdexemplary position according to one embodiment of the presentdisclosure.

FIG. 5 shows the exemplary apparatus of FIG. 1, with a mold in a fourthexemplary position according to one embodiment of the presentdisclosure.

FIG. 6 shows the exemplary apparatus of FIG. 1, with a mold in thefourth exemplary position with an exemplary press applying pressure tothe mold according to one embodiment of the present disclosure.

FIG. 7 shows the exemplary apparatus of FIG. 1, with a mold in a fifthexemplary position according to one embodiment of the presentdisclosure.

FIG. 8 shows an exemplary guide path assembly of the exemplary apparatusof FIG. 1 according to one embodiment of the present disclosure.

FIG. 9 shows a top view of the exemplary guide path assembly of FIG. 8according to one embodiment of the present disclosure.

FIG. 10 shows an exemplary cross-section of the exemplary guide pathassembly of FIG. 8 according to one embodiment of the presentdisclosure.

FIG. 11 shows a top view of an exemplary mold according to oneembodiment of the present disclosure.

FIG. 12 shows a cross-section of the exemplary mold of FIG. 11 accordingto one embodiment of the present disclosure.

FIG. 13 shows a top view of an exemplary insert according to oneembodiment of the present disclosure.

FIG. 14 shows a cross-section of the exemplary insert of FIG. 13according to one embodiment of the present disclosure.

FIG. 15 shows a top view of an exemplary static weight according to oneembodiment of the present disclosure.

FIG. 16 shows a side view of an exemplary static weight according to oneembodiment of the present disclosure.

FIG. 17 shows an exemplary press according to one embodiment of thepresent disclosure.

FIG. 18 shows a front view of an exemplary press according to oneembodiment of the present disclosure.

FIG. 19 shows a cross-section of the exemplary press of FIG. 18according to one embodiment of the present disclosure.

DETAILED DESCRIPTION

This application is related to and incorporates by reference herein thefollowing U.S. patent applications:

U.S. patent application Ser. No. 12/997,343, entitled “Material andMethod for Producing the Same,” filed on Jun. 12, 2009;

U.S. patent application Ser. No. 13/935,478, entitled “Porous PolymerLayer and Methods of Manufacture,” filed Jul. 3, 2013;

U.S. patent application Ser. No. 14/747,660, entitled “Medical Devicewith Porous Surface and Method for Producing Same,” filed Jun. 23, 2015;

U.S. patent application Ser. No. 14/587,856, entitled “Method forProducing Porous Material,” filed Dec. 31, 2014, now U.S. Pat. No.9,085,665; and

U.S. patent application Ser. No. 14/752,762, entitled “Porous Devicesand Processes for Producing Same,” filed Jun. 26, 2015.

Any incorporation by reference is not intended to give a definitive orlimiting meaning of a particular term. In the case of a conflict ofterms, this document governs.

Whether or not a term is capitalized is not considered definitive orlimiting of the meaning of a term. As used in this document, acapitalized term shall have the same meaning as an uncapitalized term,unless the context of the usage specifically indicates that a morerestrictive meaning for the capitalized term is intended. However, thecapitalization or lack thereof within the remainder of this document isnot intended to be necessarily limiting unless the context clearlyindicates that such limitation is intended.

For the purpose of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings and specific language will be used todescribe the same. It will, nevertheless, be understood that nolimitation of the scope of the disclosure is thereby intended; anyalterations and further modifications of the described or illustratedembodiments, and any further applications of the principles of thedisclosure as illustrated therein are contemplated as would normallyoccur to one skilled in the art to which the disclosure relates. Alllimitations of scope should be determined in accordance with and asexpressed in the claims.

Overview

According to particular embodiments, the systems and methods herein aredirected to an apparatus and process for producing porous materials.Prior to delving into the specific details of the apparatus, a brief andnon-limiting explanation of an exemplary process of producing porousmaterial may assist with understanding the processes set forth herein.In particular embodiments, an exemplary process for producing porousmaterials includes: 1) heating a surface of a solid piece of polymer toa processing temperature below a melting point of the polymer; 2)holding the processing temperature while displacing a porogen layerthrough the surface of the polymer to create a matrix layer of the solidpolymer body comprising the polymer and the porogen layer; and 3)removing at least a portion of the porogen layer from polymer. In one ormore embodiments, the processing temperature is approximately one (1) to38 degrees below a melting point of a polymer. As will be understood byone of ordinary skill in the art, different polymers may have differentmelting temperatures and some polymers may exhibit melting properties atmore than one temperature.

This exemplary process results in interfacial shear strength between theporous layer and solid polymer body that increases with longerprocessing times that are above a predetermined processing temperature(Tp), but below a melting point of the polymer. Further, pressureapplied to exert polymer flow of polyetheretherketone (PEEK) at aconstant rate is significantly correlated statistically (i.e., p-valueless than 0.05 as calculated by linear regression analysis) withprocessing time above a defined processing temperature of 330 degreesCelsius for up to 30 to 45 minutes. This correlation is counter toexpected results and indicates that polymer flow viscosity increaseswith increased processing time below PEEK's melting point of 343 degreesCelsius (e.g., increased processing time at about one to 13 degreesbelow 343 degrees Celsius, or between about 330 and 342 degreesCelsius).

As will be understood by one of ordinary skill in the art, “polymerflow” or “polymer flow viscosity”, as used herein may refer to any flowof a particular polymer and may not necessarily mean flow of a polymerabove a melting point of the particular polymer. In specificembodiments, “polymer flow” and “polymer flow viscosity” refer to flowof a polymer below a melting point of the polymer. Alternately, polymerflow or polymer flow viscosity may be referred to as “polymer resistanceto displacement” or the like.

As will be understood by one of ordinary skill in the art, any suitablematerials may be used in the above process. In at least one embodiment,the polymer in the above exemplary process is polyetheretherketone(PEEK). In one or more embodiments, the porogen in the above exemplaryprocess is sodium chloride grains arranged in one or more layers, suchthat when the polymer is heated it at least partially flows between thegaps of the layers of the sodium chloride particles.

The above exemplary process is further discussed in U.S. patentapplication Ser. No. 14/747,660, entitled “Medical Device with PorousSurface and Method for Producing Same,” filed Jun. 23, 2015, which isincorporated herein by reference in its entirety.

This exemplary process may be substantially conducted in whole or inpart by the systems and methods discussed herein. In particularembodiments, an exemplary processing system (apparatus) includes: 1) oneor more molds for holding a piece of material for processing; 2) a guidepath or track mechanism for guiding the one or more molds along apredefined path; 3) at least one heating element for heating the one ormore molds to a particular temperature (or temperature range) along thepredefined path; and 4) a press for applying pressure to the one or moremolds to displace porogen through a surface of the piece of material.

The apparatuses and processes above will be discussed in more detailbelow and in reference to the figures. In particular, an exemplaryprocess for creating a porous device will be described below. Followingthis discussion of the exemplary process, an exemplary apparatus forconducting the exemplary process will be discussed.

Exemplary Process

As will be further discussed, the systems and methods herein aredirected to a system and process for producing porous materials. FIG. 1provides a brief overview of an exemplary system for processing a pieceof material (e.g., thermoplastic) to include a porous layer. FIGS. 2-7depict the exemplary system of FIG. 1 as an exemplary mold assembly(e.g., of the one or more mold assemblies 1100 shown in FIG. 1) proceedsthrough the exemplary process.

Turning to FIG. 1, an exemplary processing machine 100 is shown. In theembodiment shown, the exemplary processing machine includes a trackassembly 800, one or more mold assemblies 1100, a press assembly 1700,and a work bench assembly 2000. As will further be discussed herein, thetrack assembly 800, in this embodiment, includes one or more indexers802 for moving the one or more mold assemblies 1100 along a pre-definedpath and one or more heating elements (in this embodiment, the one ormore heating elements are located below the surface of the trackassembly 800 and are not shown in FIG. 1) for heating the one or moremold assemblies 1100. As will also be further discussed herein, the oneor more mold assemblies may each include a mold, an insert (for holdinga piece of material and porogen), and a static weight for applyingpressure to the piece of material.

FIGS. 2-7 depict an exemplary process for producing a porous materialvia the system shown in FIG. 1. In the embodiment shown, a particularmold assembly 1100A of the one or more mold assemblies 1100 is shown indifferent locations on the track assembly 800 as it moves through theexemplary process. In various embodiments, the track assembly 800 isdivided into a number of processing “zones.” As will be discussedherein, each “zone” indicates an area where a particular processing stepoccurs and may generally be divided by thermal insulators or conductors(e.g., each zone has a particular heat element or temperature associatedwith it). As will be understood from discussions herein, the zones shownare exemplary and in various embodiments, each zone may vary by lengthor may include different processing steps and the number of zonesincluded in a particular track assembly may vary. In furtherembodiments, the track assembly 800 may not be easily be broken into“zones” because processing steps overlap, because thermal insulators orconductors are not present, or for other reasons.

In the embodiment shown, the particular mold assembly 1100A begins inzone 1 804, then is moved (or indexed) to zone 2 806, then to zone 3808, and to zone 4 810.

Further, in the embodiment shown, the mold assembly 1100A is shownmoving from the front right side of the track assembly 800 in FIG. 2 tothe front left side of the track assembly 800 in FIG. 7. As will beunderstood from discussions herein, this particular path is exemplaryand an exemplary mold assembly (or a different type of assembly, mold,or piece) could move along track assembly 800 in a different pattern(e.g., in a reverse order, etc.).

Turning to FIG. 2, an exemplary mold assembly 1100A is shown at thefront right of the exemplary track assembly 800 in zone 1 804. Invarious embodiments, zone 1 804 is an area along track assembly 800 forloading material, porogen, and inserts into molds and for placing astatic weight onto the material (e.g., to press a surface of thematerial onto the porogen). In particular embodiments, zone 1 804 isdefined as an area from a thermal insulator 805 to a front right cornerof the track assembly 800 (e.g., against indexer 802B). In someembodiments, zone 1 804 may be longer or shorter than as shown in FIG.2. As a particular example, the first thermal insulator 805 may be in analternate location, such as closer to the indexer 802A. Thus, in thisexample, zone 1 804 may extend from the first thermal insulator 805 atthis alternate location.

As a second particular example, the track assembly 800 may not includethermal insulator. In this second particular example, zone 1 804 mayextend from the indexer 802B along the track to the left (in theorientation shown in FIG. 2) for a predefined distance (e.g., severalcentimeters, a meter, several meters, etc.). Alternately, zone 1 804, inthis second particular example, may extend from the indexer 802B for anundefined distance or for a distance defined by the length of a singlemold (e.g., the mold 1100A). Further, in embodiments where the trackassembly 800 does not include the thermal insulator and also does notinclude indexers (e.g., the system includes another mechanism for movinga mold, as discussed below), zone 1 804 may be a predefined distancefrom another reference point on the track assembly 800 and/or may bedefined by a particular temperature associated with this zone.

In the embodiment shown in FIG. 2, the mold assembly 1100A includes amold, an insert, and a static weight (each of which will be discussedregarding FIGS. 11-16, below). In this embodiment (and others), theinsert of the mold assembly 1100A includes a void 1127 for defining aparticular shape of material. In the embodiment shown, the void 1127 isdefined such that it receives a predetermined amount of porogen and apiece of material in the particular shape for processing.

Continuing with FIG. 2, in zone 1 804, the mold assembly 1100A includesa void 1127 for receiving a predetermined amount of porogen (the void1127 is shown in FIGS. 13 and 14). The void 1127 may receive the porogenfrom any suitable source, including, for example, an operator (e.g., ahuman places a predetermined amount of porogen in the void) or a porogendispenser (e.g., a dispenser automatically dispenses porogen into thevoid 1127 based on some sensor input, such as detecting that the void1127 has moved into position below a dispensing end of the porogendispenser).

As discussed herein, the porogen may be any suitable material. Inparticular embodiments, the porogen includes sodium chloride crystals(e.g., salt). In some embodiments, the porogen is another ionic solidthat can be displaced within a polymer/thermoplastic and then removed.In further embodiments, the porogen includes particles of one or moreparticular materials such as other salts, sugars, polymers, metals, etc.

The predefined amount of porogen may be any suitable amount for creatinga porous surface of the material being processed. In particularembodiments, the predefined amount of porogen is an amount of porogen tocover a bottom surface of the void 1127. In some embodiments, thepredefined amount of porogen is packed irregular grains covering abottom surface of the void 1127 to a depth of approximately 0.2 mm to2.0 mm.

Once the porogen is received by the void 1127, the void 1127 receives apiece of material in the particular shape (e.g., on top of the porogen).In one or more embodiments, the void 1127 receives the piece of materialfrom an operator (e.g., a human may place the piece of material on theporogen in the void). In some embodiments, the void 1127 receives thepiece of material from a robot or material placing device or system.

As will be understood from discussions herein and from the materialsincorporated herein by reference, the piece of material may be anysuitable polymer and may, in particular embodiments, be any suitablethermoplastic (such as PEEK or carbon-reinforced PEEK, a material thatis at least 50% PEEK by weight, and/or another suitable thermoplastic,etc.).

After the piece of material is placed on the porogen, a static weight isplaced on top of the piece of material to press a surface of the pieceof material onto the porogen.

In particular embodiments, the static weight is placed on the materialby aligning the holes of the static weight with the pegs of the mold andsliding the static weight onto the pegs (via the holes). In variousembodiments, the static weight may be placed on the piece of material bya human operator or a robot. The static weight will be further discussedbelow in regards to FIGS. 15 and 16.

According to particular embodiments, the static weight is such that theweight applies a pressure to the material of 0.1 to 10 PSI. In variousembodiments, the static weight is such that the weight applies apressure of about 0.1 to 2.0 PSI.

The process above may vary. In particular embodiments, the porogen andpiece of material may be loaded into the insert prior to the insertbeing placed in the mold. In these embodiments, the porogen and/or thepiece of material is loaded into the insert, then the insert is loadedinto the mold in zone 1 804. In some embodiments, the insert may includepegs, opposed to the mold. In these embodiments, the porogen and pieceof material may be loaded into the insert and the static weight may beloaded onto the piece of material (e.g., via pegs on the insert, in thisembodiment) prior to the insert being placed in the mold at zone 1 804.

After a predetermined amount of time or after a particular event, theindexer 802B moves (indexes) the mold assembly 1100A to zone 2 806, theposition shown in FIG. 3. As will be further discussed herein, theindexer 802B may move the mold assembly 1100A in any suitable way. Asshown in FIG. 2, the indexer 802B is a substantially flat arm that isconnected to a hydraulic cylinder. In this embodiment, the indexer 802Bpushes the mold assembly 1100A to zone 2 806. In alternate embodiments(discussed below), the indexer 802B may move the mold assembly 1100A tozone 2 806 through another mechanism (e.g., a motor, a solenoid, a cam,etc.)

As will be understood from discussions herein, in various embodiments,indexer 802B may index mold assembly 1100A a distance equal to a lengthof the one or more mold assemblies 1100 (e.g., when the one or more moldassemblies 1100 substantially fill the track assembly 800 and aresubstantially touching as shown in FIG. 1). In these embodiments, themold assembly 1100A will be indexed more than once before reaching theposition shown in FIG. 3. In some embodiments, the system is configuredto index mold assembly 1100A a distance other than the length of the oneor more assemblies 1100. In these embodiments, the system may beconfigured to index the mold assembly any suitable distance down thetrack assembly 800 (e.g., half the length of the front portion of thetrack assembly 800, a quarter of a length of the track assembly 800,etc.).

Turning to FIG. 3, mold assembly 1100A is shown in zone 2 806. Asdiscussed above, in the embodiment shown, zone 2 806 extends from aninterior wall of the track assembly 800 (e.g., in front of the indexer802C) to the conductor 809.

Zone 2 806 as shown in FIG. 3, includes one or more heating elementsunder the surface of the track assembly 800 for heating the moldassembly 1100A to a predetermined temperature. In various embodiments,the track assembly 800 further includes various sensors (not shown) formeasuring the approximate temperature of the mold assembly 1100A.

The predetermined temperature may be any suitable temperature. Invarious embodiments, as discussed in the patents and patent applicationsincorporated herein by reference, the predetermined temperature is atemperature that is below a melting point of the piece of material. Forexample, as discussed herein, a particular polymer, PEEK, exhibitsmelting temperatures at approximately 240 and 343 degrees Celsius. Thus,the predetermined temperature is approximately one to thirty-eightdegrees below a melting point of the piece of material. In the examplewhere the piece of material is PEEK, the predetermined temperature isapproximately 305 to 342 degrees Celsius. As will be understood fromdiscussions herein, the temperature of the one or more heating elementsmay be greater than the temperature of the piece of material (e.g., someheat from the one or more heating elements is lost through heattransfer).

At a particular point in time or after a predetermined event, the systemmoves the mold assembly 1100A from zone 2 806 to under the pressassembly 1700 (via the indexer 802C), as shown in FIG. 4.

As shown in FIG. 4, the press assembly 1700 is located just before theconductor 809 (e.g., in zone 2 806). Thus, as will be understood fromdiscussions herein, the press assembly 1700 acts on the piece ofmaterial and the mold assembly 1100A while the one or more heatingelements of zone 2 806 are supplying heat (or holding a predeterminedtemperature) to the piece of material and mold assembly 1100A. Infurther embodiments, not shown, the press assembly 1700 may be locatedoutside of zone 2 806 or, in some embodiments, located in an area whereno heat is being applied to the piece of material and/or the moldassembly 1100A (e.g., the system, in a particular embodiment, is set upsuch that the piece of material is heated to a predetermined temperatureby a heat source, then moved away from the heat source to under thepress assembly 1700).

As shown in FIG. 5, the press assembly 1700, moves from a first position(e.g., at rest, above the track assembly 800) to a second position incontact with the mold assembly 1100A (e.g., in contact with the staticweight) and applies pressure to the mold assembly 1700. This pressure isadditional to the pressure applied by the static weight, which, invarious embodiments is about 0.1 to 10 PSI.

The additional pressure added by the press assembly 1700 may be anysuitable pressure. In particular embodiments, the additional pressureadded by the press assembly 1700 is up to 250 PSI. In one or moreembodiments, the additional pressure added by the press assembly 1700 isbetween 50 and 250 PSI. In at least one embodiment, the additionalpressure added by the press assembly 1700 is about 150 PSI.

As will be understood from discussions herein, in various embodiments,the additional pressure is applied to the piece of material (via thestatic weight) such that the porogen is displaced through the surface ofthe piece of material to any suitable depth. In a particular embodiment,the porogen is displaced through the surface of the piece of material toa depth of approximately 0.2 mm to 2.0 mm.

The system may be configured to apply pressure from the press assembly1700 to the piece of material for any suitable duration of time or untila particular event occurs. In various embodiments, the duration of time(that the press assembly 1700 applies pressure the piece of materialand/or mold assembly), is predetermined and ranges from one toforty-five minutes. As will be understood from discussions herein, thesystem may include a timer or other sensor, such that the press assembly1700 automatically applies pressure to the piece of material until thetimer “times out” or indicates that a duration of time as ended.

According to particular embodiments, the system includes a displacementsensor coupled to the press assembly 1700. In these embodiments, thesystem is configured to determine when the piece of material has moved apredetermined distance (e.g., when the porogen has displaced through thesurface of the piece of material to a particular depth (e.g., 0.2 to 2.0mm). In at least one embodiment, the system includes a load cell withinthe press assembly 1700 such that the press ram is moved to a particularposition (e.g., pressing a surface of a piece of material against theporogen) until the load cell no longer measures force being applied tothe piece of material, indicating that the ram is at the particularposition and is not exerting pressure on the mold assembly and thus thatthe porogen has displaced within the surface of the material.

In at least one embodiment, the system is configured to index and/ormove each of the one or more mold assemblies based on the timing of thepress assembly 1700. In these embodiments, the system is configured toindex a particular mold assembly of the one or more mold assemblies tothe next zone or to a next location upon a timer for the press assembly1700 timing out or when a displacement or load cell sensor indicatesthat the piece of material has moved downward by a particular distance(e.g., indicating that the porogen has displaced within a surface of thepiece of material by the particular distance, such as 0.2 to 2.0 mm).

Once the system receives an indication that the timer for the pressassembly 1700 has timed out or that the porogen has displaced with asurface of the piece of material by the particular distance, the systemretracts the press actuator and the mold assembly 1100A is indexedacross the conductor 809 to zone 3 808 as shown in FIG. 6.

In conductor 809 may be any suitable conductor. In particularembodiments, the conductor 809 is aluminum (or other suitable heatconducting material discussed herein) and conducts heat from zone 2 806to zone 3 808. In some embodiments, conductor 809 may be a thermalinsulator (such as a thermal insulator similar to thermal insulator 805)for separating the heat from zone 2 806 and zone 3 808.

In particular embodiments, the indexer 802C moves the mold assembly1100A from under the press assembly 1700 to the position shown in FIG. 6(e.g., in zone 3 808). As will be understood from discussions herein,the indexer 802C may move the mold assembly 1100A any suitable distance(as discussed in regards to the indexer 802A) and may move the moldassembly 1100A by pushing mold assemblies closer to the indexer 802A aparticular distance, which, in turn, pushes the mold assembly 1100A theparticular distance.

Turning to FIG. 6, mold assembly 1100A is shown in zone 3 808. Zone 3808, in the embodiment shown, includes one or more heating elementsunder the surface of the track assembly 800 for heating or holding themold assembly 1100A to or at a predetermined temperature. In variousembodiments, the track assembly 800 further includes various sensors(not shown) for measuring the approximate temperature of the moldassembly 1100A.

The predetermined temperature may be any suitable temperature and may bethe same temperature as discussed above regarding zone 2 806. In someembodiments, the one or more heating elements of zone 3 808 may heat themold and piece of material to a temperature other than that of zone 2806. As a particular example, the one or more heating elements of zone 3808 may be configured to heat the mold and piece of material to atemperature higher or lower than that of zone 2 806. In someembodiments, the one or more heating elements of zone 3 808 may hold themold and piece of material at the predefined temperature (e.g., thesystem may sense the temperature of the mold assembly 1100A and mayautomatically adjust the heat of the one or more heating elements tohold the mold and piece of material at the predefined temperature).

At a particular point in time or upon a particular event, the systemindexes the mold assembly 1100A from zone 3 808 to zone 4 810 via theindexer 802D, as shown in FIG. 7. In particular embodiments, zone 4 810does not include any heat elements and allows the mold assembly 1100A tocool.

According to particular embodiments, after the mold assembly 1100Acools, the porogen is removed from the piece of material in any suitableway, including, but not limited to by leaching, washing, etching,vaporizing, volatilizing, etc. For example, in embodiments where theporogen layer includes sodium chloride grains, some or all of the sodiumchloride grains may be removed by leaching (e.g., dissolving all or aportion of the porogen layer with a particular solvent).

As will be understood from discussions herein, a particular piece ofmaterial may be subjected to the process above more than once. In aparticular embodiment, the particular piece of material may go throughthe process above for a first surface, then again for a second surface(e.g., the particular piece of material is processed for a first surfaceas described above, then re-loaded into a mold assembly such that asecond surface is processed).

Exemplary Apparatus Track Assembly

FIGS. 8-19 show various components of the processing machine 100. Inparticular, FIGS. 8, 9, and 10 show various views of an exemplary trackassembly 800, including the one or more mold assemblies 1100. FIGS.11-16 show various views of an exemplary one of the one or more moldassemblies 1100. FIGS. 17-19 show various views of the exemplary pressassembly 1700.

Beginning with FIG. 8, exemplary track assembly 800 is shown. Asdiscussed above, the exemplary track assembly 800 moves the one or moremold assemblies 1100 through zones, such that a piece of material(loaded into each of the one or more mold assemblies) is heated andpressed to create a porous device. As previously discussed, the trackassembly 800 is, in various embodiments, broken into four zones: zone 1804; zone 2 806; zone 3 808; and zone 4 810. Further, as previouslydiscussed, the track assembly includes thermal insulator 805 andconductor 809 (not shown in FIG. 8), the one or more mold assemblies1100, and the indexers 802A, 802B, 802C, and 802D. Moreover, as shown inFIG. 8, the track assembly 800 includes one or more side panels 812, atop cover 814, a wear bar 844, a right bride 820, a top cover 826, a topcover 829, a top cover 832, a left bridge 828, and an upper track guide830.

As discussed in regards to FIGS. 2-7, the track assembly 800 includesthermal insulator 805 and conductor 809, which, in various embodiments,separate the track assembly 800 into different “zones.” As will beunderstood, in the embodiment shown, the thermal insulator 805 helpskeep heat isolated in zones 2 806 to control the temperature of thepiece of material loaded into the one or more mold assemblies 1100.

As will be understood from discussions herein, the thermal insulator 805may be in any suitable location. In particular embodiments, the thermalinsulator 805 is located such that the one or more mold assemblies 1100are within zones 1 804 for a predetermined period of time (e.g., becausethis zone, in various embodiments, applies heat to the one or more moldassemblies 1100, the distance between thermal insulator may indicate aparticular processing time for a particular mold assembly). In someembodiments, the thermal insulator 805 is located at a distance that isa function of the size of the track assembly 800. In these embodiments(and others) the thermal insulator 805 is located at approximately 60%of the distance of the front side of the track assembly (e.g., asmeasured from the front left side of the track assembly). Further, inthese embodiments, the conductor 809 may be located approximately 15% ofthe distance of the back side of the track assembly (e.g., as measuredfrom the back left side of the track assembly).

Further, as will be understood from discussions herein, the thermalinsulator 805 may be any suitable height. In various embodiments, thethermal insulator 805 is the same height as the height of the wear bar844 of the track assembly 800 (e.g., the thermal insulator 805substantially runs from the top of the work bench assembly 2000 to thetop surface of the wear bar 844 of the track assembly 800, as shown inFIG. 2). In some embodiments, the thermal insulator 805 is approximatelyhalf the height of the track assembly 800 and is mounted such that thetop surface of the thermal insulator 805 is substantially flush with atop surface of the wear bar 844, but only extends downward approximatelyhalf the distance to the top of the work bench 2000. In furtherembodiments, the thermal insulator 805 is a different suitable height(e.g., a height to insulate the one or more heating elements only, aheight of one to five centimeters, a height of two centimeters to onemeter, etc.).

There may be any suitable number of thermal insulators and/orconductors. In the embodiments shown, there is one thermal insulator andone conductor (e.g., thermal insulator 805 and conductor 809). In someembodiments, the track assembly 800 may not include any thermalinsulators or conductors (e.g., heat is applied to the one or more moldassemblies other than via heating elements under a surface of the trackassembly 800, etc.). In various embodiments, there are more than twothermal insulators (e.g., and in some embodiments, more than two zoneswhere heat is applied to the one or more mold assemblies 1100). As aparticular example, in alternate embodiments, the track assembly mayinclude four thermal insulators such that the one or more moldassemblies 1100 are held at a different processing temperature betweeneach set of two thermal insulators.

According to particular embodiments, the location of the thermalinsulator 805 and conductor 809 is a function of processing anddisplacement time. In these embodiments, the thermal insulator 805 andconductor 809 mark a distance that equates to a predetermined amount oftime that the one or more mold assemblies are held at a particularprocessing temperature prior to pressure being applied by the pressassembly 1700. As a particular example, a predetermined processing timeis approximately thirty minutes (including time at the press assembly1700, which, as shown herein, is within zone 3 808). Continuing withthis particular example, each of the one or more mold assemblies 1100 isapproximately ten centimeters in length. Further, it takes approximatelyfour minutes of the press assembly 1700 applying pressure to the pieceof material to displace the porogen through a surface of the piece ofmaterial, in this example. Continuing with this example, the distancebetween the thermal insulator 805 and conductor 809 is approximatelyseventy-six linear centimeters (e.g., it takes approximately 30 minutesfor a particular mold assembly to move from thermal insulator 805 toconductor 809 based on a four minute cycle time).

The thermal insulator 805 may be any suitable material with a lowthermal conductivity. In particular embodiments, the thermal insulator805 is one or more types of ceramics, fiberglass, glass, cellulose,polystyrene foam (Styrofoam), urethane foam, vermiculite, perlite, cork,wool, silicon, for a combination of the above. As will be understood byone of ordinary skill in the art, the material used in the thermalinsulator 805 may depend upon the amount of heat to be contained and/orapplied to the one or more mold assemblies 1100.

The thermal insulator 805 and conductor 809 may be operatively connectedto the track assembly 800 in any suitable way. In particularembodiments, the thermal insulator 805 and conductor 809 are pressedbetween two sections of the track assembly 800, such as sections of thewear bar 844 (discussed in relation to FIG. 10), the tracks guides 840,and/or insulation (as shown in FIG. 10). In some embodiments, thethermal insulator 805 and conductor 809 are operatively connected to thewear bar 844, track guides 840, other insulation, or other internal (orexternal) components of the track assembly 800 by a suitable fastener(or fasteners).

In the embodiment shown in FIG. 8, the track assembly 800 includesguides for one or more mold assemblies 1100. As further discussed below,in the embodiment shown in FIG. 8, the track assembly 800 includes oneor more track guides 840 (not shown) and the wear bar 844 (not shown)for guiding the bottom or lower portion of the one or more moldassemblies 1100 and upper guides formed by the top covers (e.g., topcovers 814, 826, 829, 832) on one side and the upper track guide 830 onthe other side for guiding an upper portion of the one or more moldassemblies 1100. In some embodiments, the track assembly 800 isconfigured to guide the one or more mold assemblies 1100 through theprocess via different guides or without guides altogether. In particularembodiments, the track assembly 800 does not include track guides, butthe one or more mold assemblies 1100 travel along a predetermined pathof the track assembly along the wear bar 844 or other surface withoutguides.

In the embodiment shown in FIG. 8, the track assembly 800 includes fourindexers: the indexers 802A, 802B, 802C, and 802D (collectively “theindexers 802”). As discussed above, the indexers 802 move each of theone or more mold assemblies 1100 along the track assembly 800. As shownin FIG. 8, indexers 802A and 802C move each of the one or more moldassemblies 1100 forward along the track assembly 800 by a distance equalto the length of one mold assembly. Further, as shown in FIG. 8,indexers 802B and 802D move each of the one or more mold assemblies adistance equal to the length of the track between zones 1 804 and zone 2806 and between zones 3 808 and zone 4 810, respectively.

As shown, the indexers 802 are located at corners of the track assembly800. In various embodiments, the indexers 802 are located in different,additional, or fewer locations (e.g., there are more or less than fourindexers). In alternate embodiments, as discussed below, the trackassembly 800 may include a different mechanism for moving the one ormore mold assemblies 1100.

The indexers 802 may be any suitable shape. In the embodiment shown, theindexers 802 are generally rectangular in shape, with a linkage portionand an index portion, where the linkage portion is connected to anactuator (e.g., a hydraulic cylinder or the like) and the indexingportion is for pushing the one or more mold assemblies 1100 along thetrack assembly 800. In particular embodiments, the linkage and indexingportions are substantially rectangular, with a length and widthsubstantially greater than a thickness of the indexer. In someembodiments, the indexing portion of the indexers 802 has a width thatis greater than the width of the linkage portion of the indexer. In theembodiment shown in FIG. 8, the indexers 802 include an indexing portionwith a width that is approximately the depth of the track of the trackassembly 800 (e.g., to push the one or more mold assemblies along thetrack guides 840 (as shown in FIG. 10) of the track assembly 800).

The indexers 802 may include any suitable material or materials. Inparticular embodiments, the indexers 802 include stainless steel. Insome embodiments, the indexers 802 include aluminum, a compositematerial, plastic, or other suitable materials. In further embodiments,the indexers 802 include reinforced steel or other metal. In stillfurther embodiments, the indexers 802 include any material suitable forresisting the high heat produced by the system.

Continuing with FIG. 8, the track assembly 800 includes one or more sidepanels 812. In various embodiments, the one or more side panels 812include sheet metal and are operatively connected to the work bench 2000and other portions of the track assembly 800. In particular embodiments,the one or more side panels 812 are made of another suitable materialand/or are connected to another portion of the track assembly 800 and/orwork bench 2000.

In the embodiment shown, the track assembly 800 includes the top covers814, 826, 829, and 832. In some embodiments, the top covers 814, 826,829, 832, insulate the interior components of the track assembly 800. Inat least one embodiment, the top covers 814, 826, 829, 832 connectvarious components of the track assembly 800 to the work bench 2000(e.g., some components of the track assembly 800 may be operativelyconnected to the top covers 814, 826, 829, 832, which are connected tothe work bench 2000 through side panel 812). In embodiments, the topcovers 814, 826, 829, 832 include an overhang or are otherwise over theone or more track guides 840 to provide an upper guide to the one ormore mold assemblies 1100 (e.g., the top covers 814, 826, 829, 832provide an upper guide to a portion of the one or more mold assemblies1100, while the one or more track guides 840 provide a lower guide tothe one or more mold assemblies 1100 as shown and discussed in regardsto FIG. 10). The top covers 814, 826, 829, 832 may include any suitablematerial, including sheet metal, stainless steel, etc.

As shown in FIG. 8, the track assembly 800 includes a track or wear bar844, which the one or more mold assemblies 1100 pass over. In particularembodiments, as will be shown in FIG. 10, the one or more moldassemblies 1100 slide along the track guides 840 and over the wear bar844. In some embodiments, the track assembly 800 may be configured suchthat the one or more mold assemblies 1100 slide directly on the wear bar844 (e.g., without the track guides 840). In at least one embodiment,the track assembly 800 is configured such that the one or more moldassemblies 1100 pass over the wear bar 844 along the track guides 840along a front and back portion of the track assembly (e.g., throughzones 1, 2, 3, and 4), but slide directly along the wear bar 844 orbridge portions of the track assembly (e.g., between zones 1 804 and 2806 and between zones 3 808 and 4 810).

In various embodiments, the wear bar 844 spans the length of travel ofthe one or more mold assemblies 1100. In some embodiments, the wear bar844 spans less than the length of travel of the one or more moldassemblies 1100 (e.g., the wear bar spans a portion of the length oftravel of the one or more mold assemblies 1100 along a front or back ofthe track assembly 800 and the one or more mold assemblies 1100 travelalong the track guides 840). The wear bar 844 and the track guides 840will be further discussed in relation to FIG. 10.

Continuing with FIG. 8, the track assembly 800 includes the upper trackguide 830. In the embodiment shown, the upper track guide 830 is forcovering the internal components of the track assembly 800 and forguiding the one or more mold assemblies 1100 down the one or more trackguides 840. In the embodiment shown, the upper track guide 830 isfastened to a portion of the track assembly such that it extends overthe one or more track guides 840 such that a portion of the one or moremold assemblies 1100 passes under the upper track guide 830 and over theone or more track guides 840.

The upper track guide 830 may include any suitable material. In oneembodiment, the upper track guide 830 is substantially sheet metal(steel). In other embodiments, the upper track guide 830 includes othersuitable materials such as other metals, ceramics, etc.

The track assembly 800 may include any suitable fasteners. As shown inFIG. 8, the track assembly 800 includes fasteners for connecting thetrack assembly 800 to the work bench 2000. As will be understood fromdiscussions herein, the track assembly 800 may include any suitablefasteners at any suitable location, including the fasteners shown inFIG. 8. In some embodiments, the track assembly 800 may include more orless fasteners than those shown in FIG. 8.

FIG. 9 shows a top view of the track assembly 800 shown in FIG. 8. FIG.9 shows a cross-section line corresponding to a cross-sectional view ofthe track assembly 800, which will be shown and discussed in FIG. 10.

Turning now to FIG. 10, this cross-sectional view of the track assembly800 includes a cross-sectional view of one of the one or more moldassemblies 1100 on the track guides 840A and 840B, which are, in theembodiment shown, operatively connected to the interior of the trackassembly 800. As shown in FIG. 10, just under the one or more moldassemblies 1100 is a wear bar 844. The wear bar 844, in the embodimentshown, is directly above a heating assembly, which includes an upperheat clamp 846, heater cartridges 848A and 848B, a lower heat clamp 850,at least one thermocouple 860, and one or more fasteners 852. Below theheating assembly, in the embodiment shown, is an air pocket 854 formedby a portion of the frame 856 of the track assembly 800 and the heatingassembly. As shown in FIG. 10, the portion of the frame 856 issurrounded by a layer of insulation 858.

In the embodiment shown, the track assembly 800 includes track guides840A and 840B. In this embodiment (and others), the track guides 840Aand 840B support the one or more mold assemblies 1100 as they areindexed around the track assembly 800 (e.g., as they are processed). Inparticular embodiments, the track guides 840A and 840B support the oneor more mold assemblies 1100 as they are indexed through zone 1 804,zone 2 806, zone 3 808, and zone 4 810.

As will be understood from discussions herein, the track guides 840A and840B may include any suitable material. As further discussed herein, oneor more heating elements (e.g., heater cartridges 848A and 848B) mayheat the one or more mold assemblies 1100 to temperature of over 300degrees Celsius in some embodiments. In these embodiments, the trackguides 840A and 840B include a material suitable for sustaining such atemperature for a long period of time (e.g., a material that will notmelt or begin to melt at this or other processing temperatures), such asstainless steel, aluminum, brass, copper, iron, gold, silver, etc. Inparticular embodiments, the track guides 840A and 840B include amaterial (or more than one material) that withstands wear from the oneor more mold assemblies traveling along (or being pushed along) thetrack guides 840A and 840B, such as stainless steel.

According to particular embodiments, the track guides 840A and 840B aresubstantially “L” or elbow shaped from a cross-sectional perspective andrun along the length of the track assembly (e.g., through zone 1 804,zone 2 806, zone 3 808, and zone 4 810) such that the track guides 840Aand 840B provide lower and side support for the one or more moldassemblies 1100. In these embodiments, (and others), the track guides840A and 840B support and “guide” the one or more mold assemblies 1100along the track assembly 800 for processing.

In at least one embodiment, the track guides 840A and 840B areoperatively connected to the frame 856 of the track assembly 800 throughany suitable fastening mechanisms (e.g., bolts, screws, nails, oradhesives (that can withstand temperatures over 300 degrees Celsius)).In particular embodiments, the track guides 840A and 840B areoperatively connected to the heat clamp 846 or insulation 858. In someembodiments, the track guides 840A and 840B are operatively connected toany other suitable part of the track assembly 800, work bench 2000, orother suitable component of the system.

Continuing with FIG. 10, in the embodiment shown, the track assembly 800includes a wear bar 844 for supporting the one or more mold assemblies1100 and for facilitating transfer of heat to the one or more moldassemblies 1100 from the heater cartridges 848A and 848B (as furtherdiscussed below). In particular embodiments, the wear bar 844 isoperatively connected to the frame 856 of the track assembly 800. Insome embodiments, the wear bar 844 is connected to the upper heat clamp846 or another part of the heater assembly of the track assembly 800. Inparticular embodiments, the wear bar 844 is located on top of the upperheat clamp 846 and between the track guides 840A and 840B. In theseembodiments, the wear bar 844 may be press fit between the track guidesand/or the upper heat clamp 846 (e.g., the wear bar 844 is connected tothe track assembly by contact, but not using any fasteners).

The wear bar 844 may include any suitable materials. According toparticular embodiments, the wear bar 844 includes aluminum to assistwith transferring heat from the heater cartridges 848A and 848B (e.g.,aluminum has high thermal conductivity and may direct and transfer heatfrom the heater cartridges 848A and 848B to the one or more moldassemblies 1100 through direct contact with the upper heat clamp and theone or more mold assemblies 1100). In some embodiments, the wear bar 844may include other materials such as steel, steel with carbon (or otheradditives), gold, copper, brass, or any other suitable material fortransferring heat from the heater cartridges to the one or more moldassemblies 1100 (e.g., an suitable material or materials with a highthermal diffusivity, which is a function of thermal conductivity,density, and specific heat).

The wear bar 844, in the embodiment shown in FIG. 10, has across-section shape that is generally rectangular and is longer than itis wide or tall. In this particular embodiment, the wear bar 844substantially runs the length of the front and back of the trackassembly 800 (e.g., through zone 1 804, zone 2 806, zone 3 808, and zone4 810). In some embodiments, the wear bar 844 has a shape other than asshown in FIG. 10, such as, for example, a cross-sectional square shape,a cross-sectional substantially triangular shape (where the one or moremold assemblies 1100 contact the wear bar 844 at the apex of thesubstantially triangular-shaped wear bar 844), a cross-sectional arcuateshape, etc.

As shown in FIG. 10, the wear bar 844 is in contact with the upper heatclamp 846. In the embodiment shown, the upper heat clamp 846 and thelower heat clamp 850 hold the heater cartridges 848A and 848B in placeunder the one or more mold assemblies 1100. Further, in this embodiment,the upper heat clamp 846 and the lower heat clamp 850 have a heatassembly fastener 852 that attaches to each of the upper heat clamp 846and the lower heat clamp 850 and passes between the heater cartridges848A and 848B. In this way, in this embodiment, the heat assemblyfastener 852 is tightened such that the upper heat clamp 846 and thelower heat clamp 850 “clamp” the heater cartridges 848A and 848B betweenthem.

The upper heat clamp 846 and the lower heat clamp 850 may include anysuitable materials, such as stainless steel, aluminum, copper, brass,etc. In various embodiments, the upper heat clamp 846 includes adifferent material than the lower heat clamp 850 to facilitate upwardstransfer of heat from the heater cartridges 848A and 848B to the one ormore mold assemblies 1100 (e.g., via the wear bar 844).

In particular embodiments, the upper heat clamp 846 and the lower heatclamp 850 are operatively connected to the frame 856 of the trackassembly 800 via one or more fasteners (e.g., bolts, screws, nuts,etc.). In at least one embodiment, the upper heat clamp 846 sits on topof a portion of the frame 856 (or insulation 858) with or without anyfasteners and is attached to the lower heat clamp 850 via the heatassembly fastener 852, thereby supporting the heater cartridges 848A and848B and lower heat clamp 850 via the frame 856.

The heater cartridges 848A and 848B may be any suitable heating elementsfor heating the one or more mold assemblies 1100. According to aparticular embodiment, the heater cartridges 848A and 848B areresistance heating elements (e.g., electricity is passed through theheater cartridges 848A and 848B to create heat) and may include metal,ceramic, polymer, and/or composite (e.g., metal and ceramic) materials.In some embodiments, the heater cartridges 848A and 848B are anotherform of heating element, such as, for example, furnace or boiler heatedelements.

The track assembly 800 may include any number of heating elements, suchas heater cartridges 848A and 848B. In the embodiment shown in thefigures, the track assembly 800 includes the heater cartridges 848A and848B (as shown in FIG. 10, in zones 1 804 and 2 806) as well as similarheating elements in zones 3 808 and 4 810. As will be understood fromdiscussion herein, the track assembly 800 may include more than fourheating elements and may include various types of heating elements(e.g., the four or more heating elements may each be a different type ofheating element). As will be further discussed below, the track assembly800 may include less than four heating elements or a single heatingelement in particular embodiments.

As shown in FIG. 10, the track assembly 800 further includes an airpocket 854 below the lower heat clamp 850 and above the frame 856. Invarious embodiments, the air pocket 854 insulates the heater cartridges848A and 848B (air has a low thermal conductivity), such that heat flowsupward toward the one or more mold assemblies 1100. As will beunderstood from discussions herein, in various embodiments, the trackassembly 800 may include insulation, a vacuum, or other materials inplace of the air pocket 854.

Continuing with FIG. 10, the track assembly 800 includes the frame 856.As will be understood from discussions herein, the frame 856, inparticular embodiments, connects the various elements of the trackassembly 800 (e.g., each of the various elements of the track assembly800 connect directly or indirectly to the frame 856). In someembodiments, the frame 856 includes one or more metals, such asstainless steel, iron, aluminum, etc.

As shown in the embodiment depicted in FIG. 10, the track assemblyincludes insulation 858, which, in the embodiment shown, at leastpartially surrounds the heating elements of the track assembly 800. Aswill be understood from discussions herein, the track assembly 800 mayinclude any suitable amount of insulation 858 and the insulation 858 maysurround three sides (of a cross-section of zone 2 808, for example) ofthe track assembly 800. In some embodiments, the insulation 858 includesfiberglass, wool, foam, rock wool, a film, carbon, etc.

As shown in FIG. 10, the track assembly 800 may include any suitablefasteners through the assembly and to attach the track assembly 800 tothe work bench 2000. In various embodiments, the one or more fasteners852 include brackets and bolts and nuts. In some embodiments, the one ormore fasteners 852 include screws or nails or an adhesive. In furtherembodiments, the one or more fasteners 852 include bonding of materialssuch as welding, etc.

According to particular embodiments, the track assembly 800 includes oneor more sensors. As shown in FIG. 10, for example, the track assembly800 includes the at least one thermocouple 860 for measuring the heat ofthe heater cartridge 848A and 848B. In various embodiments, the trackassembly 800 may include any suitable number of thermocouples to measurethe heat of the heating elements of the track assembly 800 (e.g., onethermocouple per heating element, thermocouples distributed or spacedalong a length of the track assembly 800, one or more thermocoupleslocated above the track assembly 800, etc.). In further embodiments, thetrack assembly 800 includes various other sensors such as pressuresensors, motion sensors, light sensors, weight sensors, etc.

Mold Assembly

FIGS. 11-16 show various features of the one or more mold assemblies1100. In particular, FIGS. 11-12 show features of a mold 1110 accordingto particular embodiments, FIGS. 13-14 show features of a mold insert1120 according to particular embodiments, and FIGS. 15-16 show featuresof a static weight 1130 according to particular embodiments.

Turning to FIGS. 11 and 12, the mold 1110 is shown. In the embodimentshown, the mold 1110 includes pegs 1112 and 1114 and an openingincluding curves 1116 and 1118. In the embodiment shown, the mold insert1120 (or a different mold insert) is placed in the opening, where themold insert includes outer curves that match curves 1112 and 1114.Further, in the embodiment shown, the mold 1110 includes pegs 1112 and1114 for receiving a static weight (e.g., static weight 1130).

The mold 1110 may be any suitable size. In particular embodiments, themold 1110 is substantially square and is approximately fifteencentimeters in width and length and approximately two centimeters inheight (e.g., thickness). In various embodiments, the mold 1110 issubstantially rectangular with a width of approximately fifteencentimeters and a length of approximately thirty centimeters andapproximately five centimeters in height (e.g., thickness). As will beunderstood from discussions herein, the size and shape of the mold 1110may vary (e.g., scale) based on the size of the piece of material to beprocessed.

The mold 1110 may include any suitable materials. In a particularembodiment, the mold 1110 includes stainless steel. In some embodiments,the mold 1110 includes aluminum, iron, copper, brass, or anothersuitable material. In particular embodiments, the mold 1110 and the pegs1112 and 1114 are made of different materials.

In particular embodiments, the mold 1110 includes pegs 1112 and 1114,which are integrally formed with the base of the mold 1110. In someembodiments, the mold 1110 includes pegs 1112 and 1114, which areattached to the base of the mold 1110 via a suitable fastener oradhesive.

The pegs 1112 and 1114 may be any suitable length (e.g., from the baseof the mold 1110) and diameter. According to particular embodiments, thepegs 1112 and 1114 are a length suitable for holding a static weightplaced on top of a piece of material loaded into the mold insert 1120(e.g., the pegs 1112 and 1114 are longer than the height of the piece ofmaterial above the mold insert 1120 plus a portion of the height of thestatic weight 1130). In some embodiments, the pegs 1112 and 1114 are oneto fifteen centimeters in length. In further embodiments, the pegs 1112and 1114 are less than one centimeter in length. In still furtherembodiments, the pegs 1112 and 1114 are greater than fifteen centimetersin length (e.g., fifty centimeters, one meter, two meters, etc.).Further, the pegs 1112 and 1114 have a diameter of approximately twocentimeters in a particular embodiment. In various embodiments, the pegs1112 and 1114 have a diameter of less than two centimeters, more thantwo centimeters, greater than ten centimeters, etc. In furtherembodiments, the pegs 1112 and 1114 have diameters proportional to theirlength (e.g., the longer the peg, the greater the diameter) and/ordifferent diameters.

As shown in the embodiment in FIGS. 11 and 12, the pegs 1112 and 1114are substantially cylindrical. In various embodiments (not shown), thepegs 1112 and 1114 may be any other suitable shape, such assubstantially rectangular, substantially square (from a cross-sectionalview), substantially conical, etc.

As will be understood from discussions herein, the mold 1110 travelsdown the track assembly 800 and thus may be any suitable size, dependingupon the size of the track assembly 800 and/or the amount of material tobe processed. As shown in FIG. 1, the one or more mold assembles 1100are substantially the width of the track of the track assembly 800. Invarious embodiments, the mold 1110 may be scalable to the size of thetrack assembly 800 and/or may be any suitable shape (e.g., the mold 1110may be longer, shorter, or varying widths, may be substantiallyrectangular, etc.).

FIGS. 13-14 show various features of a particular embodiment of the moldinsert 1120. The mold insert 1120, in the embodiment shown, issubstantially square and includes curves 1124 and 1122, holes 1126 and1129, void 1127, and a prong 1128. As will be understood fromdiscussions herein, the mold insert 1120 may be configured forprocessing various shapes of materials (in some embodiments, variousshapes of spinal cages). In such embodiments, the structure of the moldinsert may be different for accommodating other shapes. For example, thevoid 1127 and prong 1128 may be a different shape and size, and theprong 1128 may not exist, or there may be more than one prong 1128.

Returning to FIGS. 13 and 14, the mold insert 1120 includes the curves1124 and 1122. In various embodiments, the curves 1124 and 1122substantially match the curves 1118 and 1116 of the mold 1110 such thatthe mold insert 1120 fits within the mold 1110 for processing. In someembodiments, the mold insert may not include the curves 1124 or 1122 andmay instead include some other mechanism for insertion within mold 1110(e.g., the mold insert 1120 may fit within a void of the mold 1110 thatis not a through hole (not shown), the mold insert 1120 may includeholes to fit on pegs operatively connected to the mold 1110, etc.).

In the embodiment shown, the mold insert 1120 includes the void 1127,which may be any suitable size or shape for receiving a piece ofmaterial. In general, the void 1127 is the size and shape of the pieceof material to be processed. In the embodiment shown in FIG. 14, thevoid 1127 is a cut-out of the base of the mold insert 1120, but does notgo through the mold base 1120. In various embodiments, the void 1127 hasa depth of half the height of the mold insert 1120 (e.g., half thedistance from a face of the mold insert 1120 to an opposing face of themold insert 1120). In particular embodiments, the void 1127 has a depthof more or less than half the height of the mold insert 1120. In someembodiments, the void 1127 has a depth of approximately one centimeter(e.g., where the height of the mold insert is two centimeters).

According to particular embodiments, the mold insert 1120 includes theprong 1128, which is a portion of the base of the mold insert 1120 thathas not been removed when creating the void 1127. In variousembodiments, the prong 1128 is the same size and shape of a hole in apiece of material to be processed by the system as described herein. Inparticular embodiments, as discussed herein, the piece of material maybe a different shape than that shown in FIGS. 13 and 14 and thus theprong 1128 may not exist (e.g., this portion of the base of the moldinsert 1120 has been removed) and/or there may be multiple prongs orprongs in different locations.

In the embodiment shown, the mold insert 1120 includes the two holes1126 and 1129. The two holes 1126 and 1129 are generally for placementand removal of the mold insert 1120 within the mold 1110, e.g., when themold insert 1120 is loaded or unloaded from the mold 1110 via one ormore tools that utilize the holes 1126 and 1129. As will be understoodfrom discussions herein, the holes 1126 and 1129 may be any suitablesize and shape for use with loading and/or unloading the mold insert1120 into or from the mold 1110.

The mold insert 1120 may include other features not shown in FIGS. 13and 14. In a particular embodiment, the mold insert 1120 may be stampedwith (or otherwise include) a serial number identifying the piece ofmaterial that is processed (e.g., a serial number for identifying aresulting medical device for quality control purposes). In someembodiments, the mold insert 1120 includes multiple voids, prongs, pegs,holes, etc.

As discussed herein, once porogen and piece of material are loaded intothe mold insert 1120 and the mold insert 1120 is loaded into the mold1110, the static weight 1130 is placed onto the piece of material topress a surface of the piece of material onto the porogen. Turning toFIGS. 15 and 16, an exemplary static weight 1130 is shown. In thisembodiment, the static weight 1130 includes two holes 1132 and 1138 forreceiving the pegs 1112 and 1114 of the mold 1110. As discussed herein,the static weight 1130 applies a pressure to the piece of material, suchas, for example, approximately 0.1 PSI to 10 PSI.

As further discussed below, as shown in zone 2 806, a piece of materialloaded into the one or more mold assemblies 1100 is subjected topressure in addition to the pressure applied by the static weight 1130(described above). In these embodiments, the additional pressure isprovided by the press assembly 1700, which will be discussed in regardsto FIGS. 17-19, below.

Press Assembly

The exemplary processing machine 100 includes the press assembly 1700 asshown in FIG. 1. Features of the exemplary press assembly 1700 are shownin FIGS. 17-19. As shown in FIG. 1, the press assembly 1700 isoperatively connected (mounted) to the work bench 2000 and/or to thetrack assembly 800 and is for applying pressure to a piece of materialloaded into the one or more mold assemblies 1100 for displacing a layerof porogen through a surface of the piece of material. As discussedherein, the press assembly 1700 is operative for applying pressure tothe piece of material of approximately 50 and 250 PSI.

Turning to FIGS. 17-19, an exemplary press assembly 1700 is shown. Theexemplary press assembly 1700 includes an actuator 1702 operativelyconnected to an actuator adaptor 1704, a press mounting frame 1706(e.g., for supporting the rest of the press assembly 1700), actuatorguides 1708A and 1708B, which are operatively connected to linearbearings 1710A and 1710B. The exemplary press assembly 1700, in theembodiment shown, further includes a load cell 1712, an alignmentcoupling 1714, an adapter plate 1716, a ram platen 1718, a cam assembly1720, a linear bearing 1722, a heat shield 1724, a ram insulator 1726,and a ram head 1728. As will be understood from discussions herein, asshown in FIG. 6, the actuator 1702 moves the ram downward via the rampplaten 1718 and the actuator guides 1708A and 1708B extend downward withthe ram platen 1718.

The actuator 1702, in the embodiment shown, is a ball-screw electricactuator. As will be understood by one of ordinary skill the in the art,the ball screw actuator is a mechanical device that translates therotational motion of ball bearings (rotational motion cause byelectricity) to linear motion of a screw (e.g., an electrical motorcauses the ram to move in a vertical direction, substantiallyperpendicular to a top surface of the track assembly 800). As willfurther be understood, the actuator 1702 may be any suitable type ofactuator for applying force to a piece of material being processed. Forexample, the actuator 1702 may be a hydraulic, pneumatic, or anothertype of actuator.

The actuator 1702 is attached to the press mounting frame 1706 via theactuator adaptor 1704. In various embodiments, the actuator adaptor 1704operatively connects to the press mounting frame via one or moresuitable fasteners. In some embodiments, the actuator adaptor 1704connects to the actuator 1702 by one or more fasteners or is press fit,such that the actuator 1702 is pressed into the actuator adaptor 1704and is held in place by friction.

As shown in FIGS. 17-19, the press assembly 1700 includes actuatorguides 1708A and 1708B, which are operatively connected to the pressmounting frame 1706 via the linear bearings 1710A and 1710B. As will beunderstood by one of ordinary skill in the art, the actuator guides1708A and 1708B and linear bearings 1710A and 1710B assist the ram headin accurately applying pressure to a piece of material in a normaldirection (e.g., such that the ram head 1728 does not contact the staticweight or piece of material at an angle other than substantially 90degrees from the top of the static weight and/or piece of material).

Operatively connected to the press mounting frame 1706 is the load cell1712. In various embodiments, the load cell 1712 is a sensor formeasuring the amount of force that is being applied by the actuator. Asdiscussed above, in particular embodiments, the press 1700 lowers theram a particular distance, which presses a surface of the piece ofmaterial onto the porogen loaded into the one or more mold assemblies1100. Once the load cell 1712 returns a reading of zero force beingapplied by the actuator, the system retracts the ram to a startingposition (e.g., the reading of zero force or substantially zero forceindicates that the porogen has been displaced within the surface of thematerial).

In various embodiments, the press assembly 1700 includes a cam assembly1720 for preloading the actuator (e.g., for preventing backlash). In aparticular embodiment, the cam assembly 1720 includes a flange collarfastened to the ram platen 1718 with one or more shoulder screwsextending through the flange collar and the ram platen to a cam. In thisembodiment, when the one or more shoulder screws are turned, the campushes upward on the screw of the actuator (or on a rod or dowel thattransfers this force upward on the screw of the actuator) to preload theactuator (e.g., to prevent actuator motion without any pressure, such aswhen the balls of the actuator move without moving the screw).

The portion of the press assembly 1700 below the ram platen 1718includes various components to transfer the pressure applied by theactuator to the one or more mold assemblies 1100 (e.g., via the staticweight 1130) and to protect the components of the press assembly 1700from the heat of the heating elements of the track assembly 800 in zone2 806. In particular, in the embodiment shown, the press assembly 1700includes the linear bearing 1722 (for allowing the ram to movedownward), the heat shield 1724 and ram insulator 1726 (for protectingthe ram from the heat of the heating elements) and the ram head 1728 forcontacting the static weight 1130.

Sensors/Computing System

As will be understood from discussions herein, the processing machine100 may include one or more sensors and/or computing systems. In variousembodiments, the processing machine includes one or more thermocouplesfor measuring a temperature of the one or more heating elements (e.g.,the heater cartridges 848A and 848B) and/or mold assemblies (e.g., moldassemblies 1100) of the track assembly 800 and a load cell 1712 formeasuring the pressure applied by the actuator 1702. These sensors (andothers), in various embodiments, may be connected to a centralprocessing system for reading the information provided by these sensorsand, in some embodiments, providing adjustments to the system (e.g.,adjusting heat, pressure, etc.). In at least one embodiment, the systemis configured to receive sensor readings from the thermocouples and atleast one load cell and automatically (or substantially automatically)adjust a temperature of the heat cartridges 848A and 848B and/or thepressure applied by the actuator 1702 to the one or more mold assemblies1100.

In various embodiments, the processing machine 100 may be configured toautomatically or substantially automatically advance or index the moldassemblies based on one or more readings from the sensors of the system.As discussed above, the system may be configured to sense, via a loadcell 1712, when pressure is no longer applied to a particular moldassembly when a ram of the press assembly 1700 is at a specific depth(e.g., when a layer of porogen is displaced within a surface of a pieceof material, the load cell will register that no pressure is beingapplied by the ram at a specific depth). Upon receiving an indicationthat no pressure is being applied from the load cell 1712, the systemmay be configured to index the mold assemblies 1100 (e.g., to index anext mold assembly to a location under the press assembly 1700 forpressure to be applied the next mold assembly).

In further embodiments, the processing system 100 may include additionalsensors and/or processing capabilities. In at least one embodiment, thesystem includes an automatic porogen dispenser for dispensing a layer ofporogen into the one or more mold assemblies 1100 prior to a piece ofmaterial being loaded into the one or more mold assemblies 1100 (e.g.,prior to the piece of material being placed in contact with the layer ofporogen). In some embodiments, the processing system 100 includes atleast one robot or computing and mechanical device for placing orremoving pieces of material and/or mold inserts from the track assembly800 (e.g., the system includes a robot or robots for adding and removingthe pieces of material for processing and/or the inserts).

From the foregoing, it will be understood that various aspects of theprocesses described herein are software processes that execute oncomputer systems that form parts of the system. Accordingly, it will beunderstood that various embodiments of the system described herein aregenerally implemented as specially-configured computers includingvarious computer hardware components and, in many cases, significantadditional features as compared to conventional or known computers,processes, or the like, as discussed in greater detail herein.Embodiments within the scope of the present disclosure also includecomputer-readable media for carrying or having computer-executableinstructions or data structures stored thereon. Such computer-readablemedia can be any available media which can be accessed by a computer, ordownloadable through communication networks. By way of example, and notlimitation, such computer-readable media can comprise various forms ofdata storage devices or media such as RAM, ROM, flash memory, EEPROM,CD-ROM, DVD, or other optical disk storage, magnetic disk storage, solidstate drives (SSDs) or other data storage devices, any type of removablenon-volatile memories such as secure digital (SD), flash memory, memorystick, etc., or any other medium which can be used to carry or storecomputer program code in the form of computer-executable instructions ordata structures and which can be accessed by a general purpose computer,special purpose computer, specially-configured computer, mobile device,etc.

When information is transferred or provided over a network or anothercommunications connection (either hardwired, wireless, or a combinationof hardwired or wireless) to a computer, the computer properly views theconnection as a computer-readable medium. Thus, any such a connection isproperly termed and considered a computer-readable medium. Combinationsof the above should also be included within the scope ofcomputer-readable media. Computer-executable instructions comprise, forexample, instructions and data which cause a general purpose computer,special purpose computer, or special purpose processing device such as amobile device processor to perform one specific function or a group offunctions.

Those skilled in the art will understand the features and aspects of asuitable computing environment in which aspects of the disclosure may beimplemented. Although not required, some of the embodiments of theclaimed systems may be described in the context of computer-executableinstructions, such as program modules or engines, as described earlier,being executed by computers in networked environments. Such programmodules are often reflected and illustrated by flow charts, sequencediagrams, exemplary screen displays, and other techniques used by thoseskilled in the art to communicate how to make and use such computerprogram modules. Generally, program modules include routines, programs,functions, objects, components, data structures, application programminginterface (API) calls to other computers whether local or remote, etc.that perform particular tasks or implement particular defined datatypes, within the computer. Computer-executable instructions, associateddata structures and/or schemas, and program modules represent examplesof the program code for executing steps of the methods disclosed herein.The particular sequence of such executable instructions or associateddata structures represent examples of corresponding acts forimplementing the functions described in such steps.

Those skilled in the art will also appreciate that the claimed and/ordescribed systems and methods may be practiced in network computingenvironments with many types of computer system configurations,including personal computers, smartphones, tablets, hand-held devices,multi-processor systems, microprocessor-based or programmable consumerelectronics, networked PCs, minicomputers, mainframe computers, and thelike. Embodiments of the claimed system are practiced in distributedcomputing environments where tasks are performed by local and remoteprocessing devices that are linked (either by hardwired links, wirelesslinks, or by a combination of hardwired or wireless links) through acommunications network. In a distributed computing environment, programmodules may be located in both local and remote memory storage devices.

An exemplary system for implementing various aspects of the describedoperations, which is not illustrated, includes a computing deviceincluding a processing unit, a system memory, and a system bus thatcouples various system components including the system memory to theprocessing unit. The computer will typically include one or more datastorage devices for reading data from and writing data to. The datastorage devices provide nonvolatile storage of computer-executableinstructions, data structures, program modules, and other data for thecomputer.

Computer program code that implements the functionality described hereintypically comprises one or more program modules that may be stored on adata storage device. This program code, as is known to those skilled inthe art, usually includes an operating system, one or more applicationprograms, other program modules, and program data. A user may entercommands and information into the computer through keyboard, touchscreen, pointing device, a script containing computer program codewritten in a scripting language or other input devices (not shown), suchas a microphone, etc. These and other input devices are often connectedto the processing unit through known electrical, optical, or wirelessconnections.

The computer that effects many aspects of the described processes willtypically operate in a networked environment using logical connectionsto one or more remote computers or data sources, which are describedfurther below. Remote computers may be another personal computer, aserver, a router, a network PC, a peer device or other common networknode, and typically include many or all of the elements described aboverelative to the main computer system in which the systems are embodied.The logical connections between computers include a local area network(LAN), a wide area network (WAN), virtual networks (WAN or LAN), andwireless LANs (WLAN) that are presented here by way of example and notlimitation. Such networking environments are commonplace in office-wideor enterprise-wide computer networks, intranets, and the Internet.

When used in a LAN or WLAN networking environment, a computer systemimplementing aspects of the system is connected to the local networkthrough a network interface or adapter. When used in a WAN or WLANnetworking environment, the computer may include a modem, a wirelesslink, or other mechanisms for establishing communications over the widearea network, such as the Internet. In a networked environment, programmodules depicted relative to the computer, or portions thereof, may bestored in a remote data storage device. It will be appreciated that thenetwork connections described or shown are exemplary and othermechanisms of establishing communications over wide area networks or theInternet may be used.

While various aspects have been described in the context of a preferredembodiment, additional aspects, features, and methodologies of theclaimed systems will be readily discernible from the description herein,by those of ordinary skill in the art. Many embodiments and adaptationsof the disclosure and claimed systems other than those herein described,as well as many variations, modifications, and equivalent arrangementsand methodologies, will be apparent from or reasonably suggested by thedisclosure and the foregoing description thereof, without departing fromthe substance or scope of the claims. Furthermore, any sequence(s)and/or temporal order of steps of various processes described andclaimed herein are those considered to be the best mode contemplated forcarrying out the claimed systems. It should also be understood that,although steps of various processes may be shown and described as beingin a preferred sequence or temporal order, the steps of any suchprocesses are not limited to being carried out in any particularsequence or order, absent a specific indication of such to achieve aparticular intended result. In most cases, the steps of such processesmay be carried out in a variety of different sequences and orders, whilestill falling within the scope of the claimed systems. In addition, somesteps may be carried out simultaneously, contemporaneously, or insynchronization with other steps.

Alternate Embodiments

Alternative embodiments of the system may comprise features that are, insome respects, similar to the various components described above.Selected distinguishing features of these alternative embodiments arediscussed below.

Alternate Zones

As discussed above, the track assembly 800 may be divided into one ormore heat “zones” where heat is applied to a mold assembly (or multiplemold assemblies). In various embodiments, the system may include manyheat zones or a heat zone for each mold assembly (e.g., such that heatto each mold is more precisely controlled). In these embodiments, thesystem may include many heating elements and/or heating elements thatare approximately the size of a single mold assembly. Further, thesystem may include dynamic heating such that there are no “zones”, buttemperature can be precisely controlled at any location on the trackassembly.

In some embodiments, a mold assembly may include one or more heatingelements (e.g., opposed to or in addition to the track assemblyincluding heating elements). In these embodiments, each mold assemblymay include an electric resistance heating element (or another type ofheating element) that heats a piece of material to a specifictemperature. In various embodiments, the heating element of a moldassembly may be controlled by the system via the track assembly controlsystems. In these embodiments, the mold assembly may be configured suchthat the track assembly control systems control the heat of the moldassembly when the mold assembly is in contact with the track assembly(e.g., through electrical contacts on the mold assembly or the like). Insome embodiments, the mold assemblies may include heating controls andsensors and/or may wirelessly connect to a remote control system.

According to particular embodiments, the system includes an alternateform of heating, such as convection heating. In these embodiments, thesystem may include ovens, boilers, furnaces, heat lamps, etc. whichsubject the mold assemblies to heat as they pass through a heating area(e.g., zone). As a particular example, the system may include one ormore oven structures where the mold assemblies travel through the one ormore oven structures and are heated by the air within these structures.In these embodiments (and others), the mold assemblies may be configuredsuch that multiple surfaces of materials are processed to include pores(e.g., each mold assembly is loaded with at least one piece of materialfor processing and multiple surfaces are processed at substantially thesame time because heat may be applied to multiple (or all) surfaces ofthe at least one piece of material through convention heating).

For example, the system may include a particular oven heating structure,where the internal air of the structure is heated through any suitablemechanism (electrical heating, boiler, furnace, etc.). Further, in thisexample, at least a portion of a track assembly passes through the ovenheating structure, transporting mold assemblies through the oven heatingstructure and heating the pieces of material included in the moldassemblies as they are passed through the oven heating structure. Inthis way, in this example, multiple surfaces of the pieces of materialthat are included in the mold assemblies are heated.

Alternate Track Assemblies

As will be understood from discussions herein, the track assembly 800 ismerely exemplary and other suitable track assemblies may be constructed.In various embodiments, an alternate track assembly may include aconveyor belt opposed to indexers (e.g., indexers 802). In someembodiments, a second alternate track assembly includes the moldassemblies as integral parts of the track (e.g., mold assemblies are notremovable). In further embodiments, alternate track assemblies utilizemagnets, solenoids, pulleys, rollers, chain conveyors, wire meshconveyors, vibrating conveyors, pneumatic conveyors, screw conveyors,drag conveyors, and/or gravity to move mold assemblies.

A track assembly may be configured to move mold assemblies along anysuitable path of travel. In some embodiments, the track assembly maymove mold assemblies in a linear direction and pieces of material may beprocessed along this linear path. In various embodiments, a trackassembly may be configured to move mold assemblies along a path oftravel that is substantially circular, substantially rectangular,substantially square, or any other suitable path of travel (e.g., aspiral, an undefined shape, a combination of shapes, etc.).

Alternate Static Weight

As discussed above, the static weight is a weight that applies aconstant pressure to a piece of material loaded into a mold assembly(e.g., to press a surface of the piece of material onto a layer ofporogen while heat is applied to the surface of the piece of material).Further, as discussed above, the static weight applies approximately 0.1to 10 PSI to a piece of material. In alternate embodiments, the staticweight applies more pressure a piece of material, such as, for example,about 200 PSI. In these alternate embodiments, the system may configuredsuch that the press assembly is a quality control device to make surethat the porogen has displaced through the surface of the piece ofmaterial (e.g., the press assembly does apply additional pressure thepiece of material because the static weight has applied sufficientpressure to the piece of material to displace the porogen through thesurface).

In further embodiments, the system does not include a static weight. Inthese embodiments (and others), the system may be configured to applymore pressure to the piece of material via a press assembly (e.g., thepress assembly 1700) and/or to apply pressure to the piece of materialvia multiple press assemblies (which may be arranged in any suitable wayaround a track assembly).

Alternate Mold Assemblies

The number of mold assemblies may vary. In particular embodiments, thetrack assembly is configured to support approximately twelve moldassemblies along a particular length of the track. In some embodiments,the track assembly is configured to support more mold assemblies, suchas twenty, thirty, or fifty mold assemblies, etc. In furtherembodiments, the track assembly is configured to support less moldassemblies, such as one, two, or ten mold assemblies along a particularportion of the track.

The mold assemblies may have an alternate structure. In someembodiments, the mold assembles may not include a removable insert(e.g., the outer mold and the insert are an integral piece). In variousembodiments, the mold assemblies do not include pegs as shown in thefigures, but include another mechanism for receiving a static weight,such as a magnet (or magnets), holes (e.g., where the static weightincludes pegs), a single peg (opposed to two pegs), more than two pegs,slots, notches, etc.

Further Alternate Embodiments

According to particular embodiments, a method for processing a materialincludes: 1) providing a press assembly including a ram and a load cellfor measuring displacement of a layer of porogen through a surface of apiece of material; 2) providing the piece of material, wherein the pieceof material has been heated to a particular processing temperature for apredetermined amount of time within a mold assembly; 3) applyingpressure via the press assembly ram to the piece of material via themold assembly until the load cell measures that there is no pressurebeing applied to the piece of material and therefore the layer ofporogen has displaced through the surface of the piece of material; and4) removing the piece of material from the mold assembly.

In particular aspects, a mold assembly for processing a piece ofmaterial includes: 1) a substantially rectangular mold base with a voidfor receiving a mold insert and one or more pegs for receiving a staticweight; 2) the mold insert for being loaded into the mold base void,where the mold insert includes a non-through void for receiving a layerof ionic solid porogen and a piece of thermoplastic for processing; 3)the static weight for being loaded onto the piece of thermoplastic forapplying constant pressure to the thermoplastic, wherein the moldassembly is configured for being subjected to heat for processing thepiece of thermoplastic.

CONCLUSION

The foregoing description of the exemplary embodiments has beenpresented only for the purposes of illustration and description and isnot intended to be exhaustive or to limit the systems to the preciseforms disclosed. Many modifications and variations are possible in lightof the above teaching.

The embodiments were chosen and described in order to explain theprinciples of the systems and their practical application so as toenable others skilled in the art to utilize the systems and variousembodiments and with various modifications as are suited to theparticular use contemplated. Alternative embodiments will becomeapparent to those skilled in the art to which the present systemspertain without departing from their spirit and scope.

What is claimed is:
 1. An apparatus for processing a material, theapparatus comprising: a work bench assembly; a mold assembly, the moldassembly comprising: an outer mold body defining an opening forreceiving a mold insert; the mold insert comprising a void for receivingporogen and a piece of thermoplastic material; and a static weight forapplying pressure to the piece of thermoplastic material; a trackassembly operatively connected to the work bench assembly, the trackassembly comprising: a frame; at least one track guide operativelyconnected to the frame, the at least one track guide defining a path oftravel for the mold assembly; at least one heat source located under theat least one track guide, wherein the at least one heat source heats themold assembly to at least one predetermined processing temperature; awear bar operatively connected to the frame, the wear bar configured toconduct heat from the at least one heat source and support the moldassembly as it is moved along the path of travel; and one or moreindexers for moving the mold assembly along the path of travel; and apress assembly operatively connected to the work bench assembly, thepress assembly for applying pressure to the piece of thermoplasticmaterial, wherein the pressure applied by the press is in addition tothe pressure applied by the static weight.
 2. The apparatus of claim 1,wherein: the outer mold body comprises one or more pegs; and the staticweight comprises one or more holes corresponding to the one or morepegs, wherein the static weight is received by the outer mold body viathe one or more pegs.
 3. The apparatus of claim 1, wherein the moldinsert void comprises a non-through cavity, wherein the non-throughcavity comprises a particular shape.
 4. The apparatus of claim 3,wherein the particular shape of the non-through cavity comprises a shapeof a lumbar spinal cage.
 5. The apparatus of claim 3, wherein theparticular shape of the non-through cavity comprises a shape of acervical spinal cage.
 6. The apparatus of claim 3, wherein the moldinsert forms a protrusion within a perimeter of the non-through cavity.7. The apparatus of claim 3, wherein the non-through cavity comprises anouter perimeter with four rounded corners.
 8. The apparatus of claim 3,wherein the non-through cavity comprises an outer perimeter with atleast one curved portion.
 9. The apparatus of claim 3, wherein thenon-through cavity comprises an outer perimeter and an inner perimeter,wherein the outer perimeter is shaped to receive an outer surface of amedical device and the inner perimeter is shaped to receive an innersurface of the medical device.
 10. A track assembly for processing amaterial, the track assembly comprising: a frame; at least one trackguide operatively connected to the frame, the at least one track guidedefining a path of travel for a mold assembly; at least one heat sourcelocated under the at least one track guide, wherein the at least oneheat source heats the mold assembly to at least one predeterminedprocessing temperature; and a wear bar operatively connected to theframe, the wear bar configured to conduct heat from the at least oneheat source and support the mold assembly as it is moved along the pathof travel.
 11. The track assembly of claim 10, wherein the mold assemblycomprises: an outer mold body defining an opening for receiving a moldinsert; and the mold insert comprising a void for receiving a layer ofporogen and a piece of thermoplastic material.
 12. The track assembly ofclaim 11, wherein: the outer mold body comprises one or more pegs; andthe apparatus further comprises a static weight, the static weightcomprising one or more holes corresponding to the one or more pegs,wherein the static weight is received by the outer mold body via the oneor more pegs.
 13. The track assembly of claim 11, wherein the moldinsert void comprises a non-through cavity, wherein the non-throughcavity comprises a particular shape.
 14. The track assembly of claim 13,wherein the particular shape of the non-through cavity comprises a shapeof a lumbar spinal cage.
 15. The track assembly of claim 13, wherein theparticular shape of the non-through cavity comprises a shape of acervical spinal cage.
 16. The track assembly of claim 13, wherein themold insert forms a protrusion within a perimeter of the non-throughcavity.
 17. The track assembly of claim 13, wherein the non-throughcavity comprises an outer perimeter with four rounded corners.
 18. Thetrack assembly of claim 13, wherein the non-through cavity comprises anouter perimeter with at least one curved portion.
 19. The track assemblyof claim 13, wherein the non-through cavity comprises an outer perimeterand an inner perimeter, wherein the outer perimeter is shaped to receivean outer surface of a medical device and the inner perimeter is shapedto receive an inner surface of the medical device.
 20. An apparatus forprocessing a material, the apparatus comprising: a mold assembly, themold assembly comprising a void substantially shaped for receiving amedical device; and a track assembly comprising: a frame; at least onetrack guide operatively connected to the frame, the at least one trackguide defining a path of travel for the mold assembly; a wear baroperatively connected to the frame, the wear bar configured to supportthe mold assembly as it is moved along the path of travel; and at leastone heat source operative for heating the mold assembly to at least onepredetermined processing temperature.
 21. The apparatus of claim 20,wherein: the mold assembly comprises one or more pegs; and the apparatusfurther comprises a static weight, the static weight comprising one ormore holes corresponding to the one or more pegs, wherein the staticweight is received by the mold assembly via the one or more pegs. 22.The apparatus of claim 20, wherein the void comprises a non-throughcavity.
 23. The apparatus of claim 22, wherein the void comprises aprotrusion within a perimeter of the non-through cavity.
 24. Theapparatus of claim 23, wherein the void comprises an outer perimeterwith four rounded corners.
 25. The apparatus of claim 24, wherein thevoid comprises an outer perimeter with at least one curved portion. 26.The apparatus of claim 20, wherein the void comprises an outer perimeterand an inner perimeter, wherein the outer perimeter is shaped to receivean outer surface of the medical device and the inner perimeter is shapedto receive an inner surface of the medical device.
 27. The apparatus ofclaim 20, wherein the medical device is a lumbar spinal cage.
 28. Theapparatus of claim 20, wherein the medical device is a cervical spinalcage.
 29. The apparatus of claim 20, wherein the apparatus furthercomprises a press assembly operatively connected to the track assembly,the press assembly for applying pressure to the medical device.